EdgePRO™ 7210002

GUDID 00818365026630

EdgePRO™ System 0

US ENDODONTICS, LLC

Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system

• Primary Device ID: 00818365026630
• NIH Device Record Key: ec51394a-e09d-45e0-b6e1-2ed395c66e5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgePRO™
• Version Model Number: 7210002
• Catalog Number: 7210002
• Company DUNS: 061317427
• Company Name: US ENDODONTICS, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818365026630 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213428

FDA Product Code

• NVK: Laser, dental, soft tissue

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-03
• Device Publish Date: 2023-06-25

On-Brand Devices [EdgePRO™]

• 00818365026722: EdgePRO™ Wireless Footswitch 0
• 10818365026712: EdgePRO™ Tips Tip 3; 10mm (10 pack)
• 10818365026705: EdgePRO™ Tips Tip 2; 21mm (30 pack)
• 10818365026699: EdgePRO™ Tips Tip 2; 17mm (30 pack)
• 10818365026682: EdgePRO™ Tips Tip 1; 25mm (30 pack)
• 10818365026675: EdgePRO™ Tips Tip 1; 21mm (30 pack)
• 10818365026668: EdgePRO™ Tips Tip 1; 17mm (30 pack)
• 00818365026654: EdgePRO™ Tip Holder/Remover EdgePRO™ Tips
• 00818365026647: EdgePRO™ Tinted Multi-Wavelength Protective Filter Eyewear EdgePRO™ Tips
• 00818365026630: EdgePRO™ System 0
• 00818365026623: EdgePRO™ Replacement Yellow Air Tube EdgePRO™ System
• 00818365026609: EdgePRO™ Replacement Power Cord
• 00818365026593: EdgePRO™ Remote Interlock Plug
• 00818365026586: EdgePRO™ Protective Filter Eyewear EdgePRO™ Tinted Multi-Wavelength Protective Filter Eyewea
• 00818365026579: EdgePRO™ Patient Water Bottle
• 00818365026562: EdgePRO™ Mirror Removal Tool EdgePRO™ Replacement Yellow Air Tube
• 10818365026552: EdgePRO™ Mirror Refill Kit, 3 qty EdgePRO™ Protective Filter Eyewear
• 00818365026548: EdgePRO™ Mirror Refill Kit, 1 qty EdgePRO™ Protective Filter Eyewear
• 00818365026524: EdgePRO™ Handpiece EdgePRO™ Mirror Refill Kit, 1 qty
• 00818365026517: EdgePRO™ Fiber Replacement O-Ring Set EdgePRO™ Replacement Power Cord
• 00818365026500: EdgePRO™ Fiber Optic Protective Window
• 00818365026494: EdgePRO™ Fiber Optic Cable (only)
• 00818365026470: EdgePRO™ Cart EdgePRO™ Handpiece
• 00818365026463: EdgePRO™ Basket ONLY EdgePRO™ Cart
• 10818365026453: EdgePRO™ AAA Footswitch Batteries (2-Pack)